Process Validation & Regulatory Affairs - Pharmaceutical - Online

Process Validation and Regulatory Affairs (Pharma, L9, 60 ECTS)
Many companies operate in highly regulated areas where the demand for dynamic validation engineers, effective quality management systems and regulatory compliance leaders is growing. The aim of the Level 9 Taught Graduate Diploma of Science in Process Validation and Regulatory Affairs (Pharmaceutical) is to equip learners with competence in the appropriate legal, compliance and industry operational standards.

The programme will enable understanding of all current applicable regulations, quality management systems and effective process validation requirements. Learners will have the knowledge and skills to be able to audit all, or part of, organisation's formal Quality Management systems. Learners will acquire the ability to objectively evaluate evidence generated by systems and processes against clearly defined criteria and determine the effectiveness of these systems and processes; ensuring that they will develop skills to address and prepare for the ever-changing environment of regulatory affairs in the Pharmaceutical sector.

This Graduate Diploma of Science is delivered online and designed as an innovative multi-tiered programme to address the needs and requirements of industry-based learners and making education more accessible. It is designed so that learners can opt to select the module streams individually as Special Purpose Awards (six), complete three of the module streams to attain a Level 9 Graduate Diploma or opt for the Level 9 Masters of Science.

Critical thinking, problem solving, decision making, professionalism and management techniques will be key areas covered by the programme.

What will the time commitment be?
Each 5 credits will normally equate to approximately 100 Total Learning Hours. Total Learning Hours includes the time you spend in class (lectures, tutorials, practical elements) and the time you spend completing work outside of college. The balance between these two varies by discipline, and by level of study. You should bear in mind that the workload will increase at particular times e.g. when assignments are due.

What modules will I study?
*** Dates & Times TBC ***
Semester 1: September 2022 - December 2022
Quality Management - Mondays 6.30pm-9.30pm
The aim of this module is to facilitate an in-depth understanding of quality and quality management, from the various definitions of quality, through to the practical application of systems and processes to manage quality. Learners will be equipped with the knowledge and skills to be able audit all, or part of, organisation's formal Quality Management systems against defined criteria such as ISO 13485, ISO 9001 or 21 CFR Part 820. Learners will develop skills to become leaders and innovators in the application of Quality principles and techniques and develop as quality management professionals for senior roles in the service and manufacturing industry.

Regulatory Affairs (Pharmaceutical) - Wednesdays 7pm-10pm
Provide learners with an understanding of EU regulatory systems in the pharmaceutical field. The programme will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to Pharmaceutical in the EU market. This module will explore theory, regulations, tools and techniques used in these companies. As well as giving learners competence in the appropriate legal, compliance and operational standards in industry. This module will enhance a learner's career in regulatory affairs by developing increasing levels of competence and professionalism by obtaining a formal qualification in the pharmaceutical regulation industry.

Semester 2: January 2023 - May 2023
Auditing and Risk Management - Mondays 6.30pm - 9.30pm
Learners will gain an in-depth understanding of the application of Risk Management within organisational Quality Management Systems. Learners will acquire the ability to objectively evaluate evidence generated by systems and processes against clearly defined criteria and determine the effectiveness of these systems and processes. There will also be a focus on managing external audits by second and third parties (customers and regulators/notified bodies). Learners will develop skills to become leaders and innovators in the application of Quality principles and techniques and develop as quality management professionals for senior roles in the service and manufacturing industry.

Advanced Regulatory Affairs (Pharmaceutical) - Wednesdays 7pm - 10pm
Understanding of the utilisation of standards, FDA and other jurisdictions' guidance documents and technical writing. The module will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to Pharmaceutical in the world market.

Computer Systems Validation (Elective) - Thursdays 7pm-10pm
An overview of software validation in a manufacturing or software environment. The focus will be on software validation in a manufacturing or software environment. To evaluate software validation approaches, models, development, implementation, testing and maintenance of validated software. The importance and application of validation management, reporting and risk management in a manufacturing/software environment will be defined and evaluated.

Semester 3: September 2023 - December 2023
Advances Process Engineering - Tuesdays 7pm - 10pm
The aim of this modules is to provide the learner with a knowledge of process engineering management in a manufacturing environment. A learner will be able to evaluate process types, designs, layouts, process analysis, forecasting of product, capacity planning while ascertaining a knowledge of current technologies and automation used in the manufacturing.

Process Validation (Elective) - Thursdays 7pm - 10pm
Provide the learner with an overview of process and product validation in manufacturing environments. The focus will be on Process validation with emphases on the tools and techniques that are used in the operations and manufacturing environment; to ensuring that operations are efficient in terms of using as few resources as needed, compliance with regulatory requirements and be effective in terms of meeting customer requirements.

*** Dates & Times TBC ***

What are the entry requirements?
a) A minimum honours bachelor degree (Level 8) in any discipline with minimum two years relevant work based experience and/or ability, evidenced by an RPL portfolio of prior experience and learning

Or
(b) A minimum ordinary bachelor degree (Level 7) in any discipline with minimum three years relevant work based experience and/or ability, evidenced by an RPL portfolio of prior experience and learning

Or
(c) Equivalent Qualifications. Applicants with equivalent qualifications on the European and International
frameworks will also be considered. International students must evidence a proficiency in English language for
example IELTS 6.0

Recognised Prior Learning (RPL) / Special Case Registrations: Prospective participants who do not meet the entry requirements for the programme detailed above, but who may qualify for admission by meeting certain other equivalent criteria, should notify the Flexible Learning Office and request consideration under RPL. Please submit your application online and then email all your supporting documents to Springboard@lit.ie

Application Deadline: TBC for September 2023
Register Your Interest: https://lit.ie/Register-Your-Interest?coursecode=LC_EPVRM_NOL(PHARM)

15 Months

Delivery
8 hours per week. Exact timetable TBC.

Semester 1: September - December (2 evenings per week).
Semester 2: January - May (2 evenings per week).
Semester 3: September - December (2 evenings per week).
Number of Weeks: 12 per semester

Number of Days/Evenings per week: 2 evenings per week
Delivery Day/Evening: Monday & Wednesday (TBC Semester 1)
Number of Hours per day/evening: 3 hours
Times: 6:30pm - 9:30pm (Mon) 7pm to 10pm (Wed)?

Lectures will be delivered 100% online via Moodle/MSTeams. Lectures will be recorded and available to watch back.

Are there opportunities for further study?
Students can transfer on to the Masters of Science in Process Validation and Regulatory Affairs. Holders of this Level 9 Graduate diploma will be required to complete one 30 credit Dissertation Module to obtain the L9 Masters.

What are the career prospects?
There are multiple roles a graduate from the programme can seek in disciplines such as Quality Engineering, Management, Auditing, Compliance, Legal and Regulatory affairs.

Furthermore, there are multiple roles a graduate from the programme can seek in areas such as Regulatory Engineer, Process Engineer, Validation Engineer, Quality Engineers, Regulatory Affairs Management, Process Engineering Management, Validation Management, Quality Management, Quality Management Systems, Quality Assurance, Compliance and Auditing Management, Risk Management.

International Opportunities:
The content of the modules will be seen to reflect a globalised environment .This is demonstrated by the regulatory affairs module stream which focuses on EU, US and worldwide regulatory affair bodies.

This is further demonstrated through the quality management module stream as learners will receive internationally recognised award in ISO9001:2015 Lead Auditor, which equips learner to be lead auditors world-wide. Thus, will be equipped with the knowledge and skills to be able audit all, or part of, organisation's formal Quality Management systems against defined criteria such as international standards ISO 13485, ISO 9001 or 21 CFR Part 820.